UMIN-CTR Clinical Trial

Basic information
Public title	Kanagawa-Acute cardiovascular registry
Acronym	K-ACTIVE
Scientific Title	Kanagawa-Acute cardiovascular registry
Scientific Title:Acronym	K-ACTIVE
Region	Japan

Condition
Condition	Acute myocardial infarction
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the incidence of cardiovascular event (in hospital, 12months) in patients with acute myocardial infarction in Kanagawa
Basic objectives2	Others
Basic objectives -Others	To compare the data of acute myocardial infarction to other prefectures
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of cardiovascular event (in hospital, 12months)
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	acute myocardial infarction (ST-elevation and non ST-elevation) within 24 hours from onset (including cardiopulmonary arrest)
Key exclusion criteria	none
Target sample size	2000

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Suzuki
Organization	Showa University Fujigaoka Hospital
Division name	Department of Cardiology
Zip code	227-8501
Address	1-30 Fujigaoka, Aoba-ku, Yokohama 227-8501, Kanagawa, Jaoan
TEL	0459711151
Email	hrsuzuki@med.showa-u.ac.jp

Public contact
Name of contact person	1st name Hiroshi Middle name Last name Suzuki
Organization	Showa University Fujigaoka Hospital
Division name	Department of Cardiology
Zip code	227-8501
Address	1-30 Fujigaoka, Aoba-ku, Yokohama 227-8501, Kanagawa, Jaoan
TEL	045-971-1151
Homepage URL
Email	hrsuzuki@med.showa-u.ac.jp

Sponsor
Institute	Conference in Kanagawa cardiovascular emergency and registry
Institute
Department

Funding Source
Organization	Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board of Showa University Fujigaoka Hospital
Address	1-30 Fujigaoka, Aoba-ku, Yokohamashi, Kanagawa
Tel	0459711151
Email	hrsuzuki@med.showa-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	昭和大学藤が丘病院他55施設

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results	10,140 cases were registered at 10/02/2021.
Results date posted	2021 Year 10 Month 03 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 09 Month 28 Day
Date of IRB	2015 Year 07 Month 01 Day
Anticipated trial start date	2015 Year 10 Month 01 Day
Last follow-up date	2034 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

(1) Study design: registry (2) Study period: 2015.10.1-(Indefinite) (3) Patients: Acute myocardial infarction (ST-elevation and non ST-elevation) addmitted within 24 hours from onset (including cardiopulmonary arrest) to registered hospital in Kanagawa (4)Registration item 1.General information: admission day, time 2. Patient information: age, gender, hospital visit, onset time, onset-door-time 3. Complication: DM, DLp, HT, smoking, history of hospital visit 4. Visit information: BP, Pulse, Rhythm, Killip, CPA, Cr 5. Prehospital ECG: recording, transmission 6. AMI: type, site, history, peak CK, peak CKMB 7. Therapy: PCI, thrombolysis 8. Prognosis: in-hospital, 30 days, 12 months, reason of death, MACE

Management information
Registered date	2015 Year 09 Month 29 Day
Last modified on	2021 Year 10 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022113